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SIEMENS MEDICAL SOLUTIONS USA, INC recalls ARTIS One Angiographic X-Ray System
Recalled February 5, 2025 · FDA recall Z-0922-2025 · SIEMENS MEDICAL SOLUTIONS USA
Hazard
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user. · FDA Class II
Units
1140
Sold at
23 Distributed in the US
Description
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Product
ARTIS One Angiographic X-Ray System
Manufacturer(s)
SIEMENS MEDICAL SOLUTIONS USA, INC
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →